Recruiting
Phase 1

Cu-AKY-2519, Ac-AKY-2519

Sponsor:

Aktis Oncology, Inc.

Code:

NCT07887971

Conditions

NSCLC

NSCLC (Advanced Non-small Cell Lung Cancer)

ES-SCLC

Small Cell Lung Cancer Extensive Stage

B7H3

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[225Ac]Ac-AKY-2519 (therapeutic)

[64Cu]Cu-AKY-2519 (imaging)

Study Details

Brief summary:

This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.

Conditions

NSCLC

NSCLC (Advanced Non-small Cell Lung Cancer)

ES-SCLC

Small Cell Lung Cancer Extensive Stage

B7H3

Study ID

NCT07887971

Start date

Nov, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologic or cytologic confirmation of locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma
  • Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
  • ECOG Performance Status of 0 or 1
  • Adequate end-organ function
  • Ability to give informed consent and comply with study requirements
  • Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids

Exclusion Criteria:

  • Prior treatment with a B7-H3 targeted therapy
  • Prior treatment with a targeted radiotherapy
  • Received an investigational agent within the previous 28 days
  • Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy within the previous 28 days
  • Impaired cardiac function or clinically significant cardiac disease
  • Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

Study Design

Enrollment

152 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: [225Ac]Ac-AKY-2519

Interventions

[225Ac]Ac-AKY-2519 (therapeutic)

\[225Ac\]Ac-AKY-2519 Injection

[64Cu]Cu-AKY-2519 (imaging)

\[64Cu\]Cu-AKY-2519 Injection

Primary outcome measure

  • Part 1: Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519 [ Time Frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519 ]
  • Part 1: Occurrence of dose-limiting toxicity (DLT) in participants [ Time Frame: From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days) ]
  • Part 2: Objective Response Rate (ORR) [ Time Frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519 ]

Central Contacts and Locations

Locations

Biogenix Molecular, LLC

Recruiting

Miami, Florida, United States, 33165

Contacts

Study Coordinator

786-791-1799rrippin@cira-health.com

More Information

Sponsor

Aktis Oncology, Inc.

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Aktis Oncology, Inc. on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.